BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23 G X .75 IN. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 6998495 · Received November 2, 2017

    Report

    Report Number
    1024879-2017-00350
    Event Type
    Malfunction
    Date Received
    November 2, 2017
    Date of Event
    May 31, 2016
    Report Date
    October 24, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903673426
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. FDA NOTIFIED?: THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON (B)(6) 2016 VIA MEDWATCH # (B)(4). RESULTS - A SAMPLE WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6061791. PHOTOS OF THE RETURNED CUSTOMER SAMPLE SHOW EVIDENCE OF SEPARATION OF THE FRONT AND REAR BARREL. CONCLUSION: MISALIGNMENT OF THE FRONT AND REAR BARRELS LEADING TO DAMAGED PARTS, ALLOWING FOR THE BARRELS TO BECOME SEPARATED UPON ACTIVATION. CAPA (B)(4) OPENED FOR THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER BLOOD WAS DRAWN FROM PATIENT, THE ACTIVATION OF THE SAFETY OF THE 23 G X .75 IN. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH 12 IN. TUBING AND LUER ADAPTER CAUSED THE PROTECTIVE COVER TO FALL APART, LEAVING THE NEEDLE EXPOSED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775115 23 G X .75 IN. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD COLLECTION SET JKA BECTON, DICKINSON & CO., (BD) 6061791 50382903673426

    Patients

    Seq Age Sex Outcome Treatment
    1 Other